Trial Outcomes & Findings for Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery (NCT NCT05685511)
NCT ID: NCT05685511
Last Updated: 2026-03-31
Results Overview
Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms. PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Baseline and 3 months post-operatively
Results posted on
2026-03-31
Participant Flow
813 oncologic patients were assessed for eligibility, 330 did not meet inclusion criteria, 324 declined participation, and 54 were excluded for other reasons.
Participant milestones
| Measure |
Intervention Bundle (Behavioral Activation + Medication Optimization)
* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
|
Usual Care
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
47
|
51
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Intervention Bundle (Behavioral Activation + Medication Optimization)
* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
|
Usual Care
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Medical Condition
|
1
|
0
|
Baseline Characteristics
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
Baseline characteristics by cohort
| Measure |
Intervention Bundle (Behavioral Activation + Medication Optimization)
n=52 Participants
* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
|
Usual Care
n=48 Participants
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
66.9 years
STANDARD_DEVIATION 6.6 • n=28 Participants
|
67.3 years
STANDARD_DEVIATION 6.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=4 Participants
|
42 Participants
n=28 Participants
|
84 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=4 Participants
|
6 Participants
n=28 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=4 Participants
|
48 Participants
n=28 Participants
|
100 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
15 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=4 Participants
|
41 Participants
n=28 Participants
|
85 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=4 Participants
|
48 participants
n=28 Participants
|
100 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months post-operativelyChange in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms. PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety).
Outcome measures
| Measure |
Intervention Bundle (Behavioral Activation + Medication Optimization)
n=52 Participants
* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
|
Usual Care
n=48 Participants
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.
|
Total
n=100 Participants
This includes participants in the Intervention Bundle arm and in Usual Care arm.
|
|---|---|---|---|
|
PHQ-ADS
Month 3
|
9.39 points
Standard Error 1.40
|
12.65 points
Standard Error 1.52
|
11.02 points
Standard Error 1.16
|
|
PHQ-ADS
Baseline
|
18.35 points
Standard Error 1.35
|
16.67 points
Standard Error 1.52
|
17.51 points
Standard Error 1.14
|
|
PHQ-ADS
Month 1
|
10.95 points
Standard Error 1.37
|
12.52 points
Standard Error 1.53
|
11.74 points
Standard Error 1.15
|
Adverse Events
Intervention Bundle (Behavioral Activation + Medication Optimization)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Bundle (Behavioral Activation + Medication Optimization)
n=53 participants at risk
* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
|
Usual Care
n=52 participants at risk
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bump on the head due to a fall
|
1.9%
1/53 • From randomization through completion of study (estimated to be 4-6 months).
|
0.00%
0/52 • From randomization through completion of study (estimated to be 4-6 months).
|
Additional Information
Benjamin D. Kozower, M.D, MPH
Washington University School of Medicine
Phone: 314-362-8089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place